This invention relates to an apparatus and method for the percutaneous introduction of intra-aortic balloons into the human body, including an intra-aortic balloon which can be introduced percutaneously.
In the use of intra-aortic ballons, the balloon must be positioned within aorta. In general, the balloons are formed as part of a catheter.
Intra-aortic balloon pumping is a recognized technique for cardiac assistance for a failing heart. It is also a recognized technique cardiogenic shock. Further, it has been used for such purposes as helping to wean a patient away from cardiopulmonary bypass, to support a patient during a difficult postoperative period, and to provide a pulsatile flow through the linear flows supplied by the cardiopulmonary bypass device. Intra-aortic balloon pumping has also been used therapeutically after myocardial infarction to limit the extension of necrosis and it also has been used as a therapy for angina pectoris.
The intra-aortic balloon catheters of the prior art are relatively stiff and bulky and have a large "entering" cross section, i.e. the size of the opening needed to pass the balloon into the body.
The femoral artery has heretofore been used for insertion of the prior art balloon catheters because of the large diameter of that artery. However, due to the large entering cross-sections of the prior art balloons, considerable and rather delicate surgery must be performed in order to reach and isolate the femoral artery in a manner which enables the balloons to be introduced. In many cases, only cardio-pulmonary surgeons are willing or able to undertake this surgery, thus limiting the use of the otherwise advantageous balloon. Further, considerable difficulty is often encountered in the healing of these surgical incisions because of their location in the groin.
Additionally, the stiffness of prior art balloon devices along their lengths prevents precise maneuverability of the catheter within the vascular structure and thereby limits their potential for efficacy.
In our aforesaid prior application, a balloon is provided of a reduced cross-section whose ends may be connected to be rotated relative to each other, or to the catheter to twist, or wind, the balloon around a central shaft. However, this approach gives rise to the formation of oblique wrinkles on the wrapped profile exposing the interior walls of the artery to said wrinkles thereby making it somewhat more difficult to insert the balloon and dependent on complete unwrapping to achieve efficacy.